A Helping Osteoarthritis Patients to Walk With NSAID
Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
Summary
We lack of effective analgesic treatments to help walking patients with painful hip/knee
osteoarthritis. We therefore imagined a new strategy lying on a multimodal rehabilitation
walking program with the help of a transient intake of nonsteroidal anti-inflammatory drug
(NSAID). NSAIDs are indeed known to act specifically on pain at movement, but their
continuous intake would induce unacceptable side effects. To optimize the benefit/risk
balance, the molecule to be chosen must fit to the patient's profile, and its intake should
cover only the period of interest, i.e. planned walks. Our multimodal rehabilitation program
will also include physical techniques such as appropriate footwear, a patient's education
aiming at reducing fear/avoidance and spotting side effects of NSAIDs, and a prescription
frame to avoid any overdosing.
This clinical study is a single-center, non-randomized, open label, one-arm trial, using
drugs prescribed according to their label (i.e. osteoarthritis pain), pending a reinforced
monitoring of side effects.
The primary endpoint is to evaluate efficacy and tolerance of a tailored and transient
administration of NSAID within a rehabilitation walking program in patients with painful
hip/knee osteoarthritis.
Secondary endpoints are to evaluate the adherence to the program and the factors influencing
adherence; to identify the less well tolerated conditions of treatment (one condition being
one molecule for one patient profile); to identify the factors of success among a set of
baseline demographic, morphometric and psychometric variables; and to study the role of
central sensitization (assessed by temporal summation) on the efficacy of treatment.
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborators:
Direction de la Recherche Clinique et des Innovations, CHU de Clermont-Ferrand, France Fondation Apicil Inserm U1107 " Neuro-Dol ", Clermont-Ferrand, France Médecine du Sport et Explorations Fonctionnelles, CHU de Clermont-Ferrand, France Médecine Physique et Réadaptation, CHU de Clermont-Ferrand, France Plateforme d'Investigation Clinique, INSERM CIC1405, CHU de Clermont-Ferrand, France Rhumatologie, CHU de Clermont-Ferrand, France SARL BOUCHARENC, Saint-Chély d'Apcher, France Université Clermont-Auvergne, France